Functional Voice DisorderNCT02518425
Improvement in Acoustic Voice Characteristics in Functional Dysphonia After Therapy
An observational study of Functional Voice Disorder, run by University of Zurich at 1 site in Switzerland.
Trial summary
In a retrospective analysis of already existing clinical assessment data from patients with functional voice disorders the following aspects will be sampled, encoded and analysed: Outcomes pre and post treatment of 1. subjective voice symptoms measured by Voice Handicap Index (VHI-9i), 2. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Functional Voice Disorder
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2015to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with functional voice disorders
Who may be able to join
- informed consent; patients 20 to 70 years with functional voice disorder; -diagnostics and voice therapy at University Hospital Zurich;
- full pre- and post treatment voice assessment (videostroboscopy, subjective self- assessment, instrumental acoustic and perceptual analysis).
Who cannot join
- known neurologic and psychiatric disease,
- hearing disorder,
- surgery of the head and neck area or intubation (for any reason) in last 18 months.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clinic for Otorhinolaryngology University Hospital Zurich
Zurich, Canton of Zurich, 8091
About this study
Official title: Which Instrumental Acoustic Voice Parameters Indicate Vocal Improvement After Voice Therapy in Patients With Functional Dysphonia
In a retrospective analysis of already existing clinical assessment data from patients with functional voice disorders the following aspects will be sampled, encoded and analysed: Outcomes pre and post treatment of
- subjective voice symptoms measured by Voice Handicap Index (VHI-9i),
- perceptual voice symptoms according to Grading-Roughness-Breathiness-Asthenia-Strain Scale (GRBAS Scale),
- instrumental acoustic analysis parameters Jitter (%), speaking voice profile: mean and range of speaking pitch and intensity, max. intensity and mean pitch of calling voice, singing voice: min./max. and range of pitch and intensity, maximum phonation time, Dysphonia Severity Index (DSI).
- Conditions
- Functional Voice Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Instrumental acoustic voice parameters
Instrumental acoustic parameters are determined by a computer-assisted analysis of voice recordings. In the present study the following parameters are measured before and after voice therapy: Jitter % (deviation of fundamental frequency), mean and range of speaking pitch and intensity, maximum intensity and mean pitch of calling voice, minimum and max. and range of pitch and intensity of the singing voice, and the composite measure Dysphonia Severity Index (DSI).
Measured: Before (initial diagnosis) and after voice therapy, expected average of 11-20 weeks after initial diagnosis)
Secondary outcomes (2)
Subjective voice symptoms
Subjective voice symptoms are measured before and after voice therapy by the patient questionnaire "Voice Handicap Index" (VHI-9i).
Measured: Before (initial diagnosis) and after voice therapy, expected average of 11-20 weeks after initial diagnosis)
Perceptual voice symptoms
Perceptual (hearable) voice symptoms are determined by the examiner before and after voice therapy using GRBAS Scale (Grading-Roughness-Breathiness-Asthenia-Strain Scale).
Measured: Before (initial diagnosis) and after voice therapy, expected average of 11-20 weeks after initial diagnosis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Voice DisorderStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joerg E Bohlender, MD, Principal investigator, University Hospital Zurich, Department of Otorhinolaryngology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518425
- Sponsor's protocol ID
- BJ_02_02_2015
- Status last verified
- May 2016
- First submitted
- 9 Apr 2015
- Last updated
- 16 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Which Instrumental Acoustic Voice Parameters Indicate Vocal Improvement After Voice Therapy in Patients With Functional Dysphonia
- ClinicalTrials.gov ID
- NCT02518425
- Acronym / sponsor ID
- BJ_02_02_2015
- Conditions
- Functional Voice Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In a retrospective analysis of already existing clinical assessment data from patients with functional voice disorders the following aspects will be sampled, encoded and analysed: Outcomes pre and post treatment of
- subjective voice symptoms measured by Voice Handicap Index (VHI-9i),
- perceptual voice symptoms according to Grading-Roughness-Breathiness-Asthenia-Strain Scale (GRBAS Scale),
- instrumental acoustic analysis parameters Jitter (%), speaking voice profile: mean and range of speaking pitch and intensity, max. intensity and mean pitch of calling voice, singing voice: min./max. and range of pitch and intensity, maximum phonation time, Dysphonia Severity Index (DSI).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with functional voice disorders
Key inclusion criteria (2 listed)
- informed consent; patients 20 to 70 years with functional voice disorder; -diagnostics and voice therapy at University Hospital Zurich;
- full pre- and post treatment voice assessment (videostroboscopy, subjective self- assessment, instrumental acoustic and perceptual analysis).
Key exclusion criteria (3 listed)
- known neurologic and psychiatric disease,
- hearing disorder,
- surgery of the head and neck area or intubation (for any reason) in last 18 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Instrumental acoustic voice parameters
Time frame: Before (initial diagnosis) and after voice therapy, expected average of 11-20 weeks after initial diagnosis)
Instrumental acoustic parameters are determined by a computer-assisted analysis of voice recordings. In the present study the following parameters are measured before and after voice therapy: Jitter % (deviation of fundamental frequency), mean and range of speaking pitch and intensity, maximum intensity and mean pitch of calling voice, minimum and max. and range of pitch and intensity of the singing voice, and the composite measure Dysphonia Severity Index (DSI).
2 secondary outcomes
Subjective voice symptoms
Time frame: Before (initial diagnosis) and after voice therapy, expected average of 11-20 weeks after initial diagnosis)
Perceptual voice symptoms
Time frame: Before (initial diagnosis) and after voice therapy, expected average of 11-20 weeks after initial diagnosis)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joerg E Bohlender, MD principal investigator
University Hospital Zurich, Department of Otorhinolaryngology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Voice Disorder, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Instrumental acoustic voice parameters (time frame: Before (initial diagnosis) and after voice therapy, expected average of 11-20 weeks after initial diagnosis)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2016.